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    Summary
    EudraCT Number:2015-000417-44
    Sponsor's Protocol Code Number:PHP-OCM-301A
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-000417-44
    A.3Full title of the trial
    A Single-arm, Multi-center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma
    Une étude ouverte, multicentrique, à bras unique pour évaluer l’efficacité, l’innocuité et la pharmacocinétique du traitement par Melphalan/HDS chez les patients atteints d’un mélanome oculaire avec métastases au foie
    Een multicenter, open-label onderzoek met één arm ter evaluatie van de werkzaamheid, veiligheid en farmacokinetica van behandeling met melfalan/HDS bij patiënten met leverdominant oogmelanoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single-arm, Multi-center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with cancer of the eye that has spread to the liver
    A.4.1Sponsor's protocol code numberPHP-OCM-301A
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDelcath Systems, Ltd
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDelcath Systems, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDelcath Systems, Inc
    B.5.2Functional name of contact pointClinical Trials Desk
    B.5.3 Address:
    B.5.3.1Street Address1633 Broadway, Suite 22C
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10019
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12124892100
    B.5.5Fax number+12124892102
    B.5.6E-mailjshea@delcath.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Melphalan Hydrochloride for injection
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Institutional LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMelphalan
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMelphalan
    D.3.9.1CAS number 3223-07-2
    D.3.9.3Other descriptive nameMELPHALAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB126965
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatic-Dominant Ocular Melanoma
    E.1.1.1Medical condition in easily understood language
    Cancer of the eye that has spread to the liver
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10068117
    E.1.2Term Metastatic ocular melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective Response Rate (ORR) (complete response + partial response) as determined by Independent Central Review Committee (IRC).
    E.2.2Secondary objectives of the trial
    • Duration of Response (DOR) as determined by Independent Central Review Committee.
    • Disease Control Rate (DCR) as determined by Independent Central Review Committee.
    • Overall Survival (OS).
    • Progression Free Survival (PFS) as determined by Independent Central Review Committee.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria for study entry:
    1. Male or female patients ≥ 18 years of age.
    2. Patients must weigh ≥ 35 kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
    3. 50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver.
    4. Disease in the liver must be measurable by computed tomography (CT) and/or magnetic resonance imaging (MRI).
    5. Evidence of limited extrahepatic disease on preoperative radiological studies is acceptable if the life threatening component of disease is in the liver. Limited extrahepatic disease is defined in this protocol as follows: metastasis in bone, subcutaneous, lung or lymph nodes that is amenable to resection or radiation and has a defined treatment plan. Patients with extra-hepatic tumor burden which does not have a defined treatment plan (i.e. monitor or is unable to be resected or radiated) must not be included in the trial.
    6. Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and MRI of the liver) must be performed within 28 days prior to eligibility. An MRI of the liver is required at screening to validate that CT accurately reflects the extent of disease in the liver. For patients with MRI intolerance, a 3-phase liver CT is to be done in place of liver MRI.
    7. Patients must not have had chemotherapy, radiotherapy, chemoembolization, radioembolization, or immunoembolization for their malignancy within 30 days prior to treatment and must have recovered from all side effects of therapeutic and diagnostic interventions except those listed in Appendix B of the study protocol. 8. Patients receiving anti programmed cell death protein 1 (PD-1) immunotherapy such as pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen 4 blocking antibody such as ipilimumab must have completed treatment 8 weeks prior to study eligibility.
    9. Patients must have an ECOG PS of 0-1 at screening .
    10. Patients must have adequate hepatic function as evidenced by total serum bilirubin ≤1.5 x the upper limit of normal (ULN) and a prothrombin time (PT) within 2 seconds of the upper normal limit. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) must be ≤ 2.5 x ULN.
    11. Patients must have a platelet count > 100,000/μL, hemoglobin ≥ 10.0 gm/dL, white blood cell count (WBC) > 2,000/uL, absolute neutrophil count ≥ 1.5 x 109/L, and a serum creatinine ≤ 1.5 mg/dL unless the measured creatinine clearance is > 40 mL/min/1.73 m2.
    12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (β-human chorionic gonadotropin) within 7 days prior to eligibility.
    13. Provided signed informed consent.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study entry:
    1. Patients with Child-Pugh Class B or C cirrhosis or with evidence of portal hypertension by history, endoscopy, or radiologic studies.
    2. Those with New York Heart Association functional classification II, III or IV active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.
    3. History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
    4. Women of childbearing potential (WOCBP, i.e., fertile meaning not permanently sterilized and having had a menstrual period within the past 12 months): unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment.
    5. WOCBP and fertile males (not permanently sterile by bilateral orchidectomy) unwilling or unable to use highly effective contraception method from consent to at least 6 months after the last administration of study treatment. (combined hormonal contraception; progestogen-only hormonal contraception; Intrauterine device, intrauterine hormone-releasing system; bilateral tubal occlusion, vasectomized partner or sexual abstinence).
    6. Females that are pregnant or breastfeeding patients.
    7. Patients taking immunosuppressive drugs; however, oral corticosteroids ≤ 10 mg/ day are allowed.
    8. Patients who are unable to be temporarily removed from chronic anti-coagulation therapy.
    9. Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy.
    10. Patients with severe allergic reaction to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids.
    11. Patients with a history of or known hypersensitivity to melphalan or the components of the Melphalan/HDS system.
    12. Patients with latex allergy.
    13. Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
    14. Patients with a history of bleeding disorders or evidence of intracranial abnormalities which would put them at risk for bleeding with anti-coagulation (e.g., strokes, active metastases).
    15. Patients with a history of gastrinoma; NOTE: For patients with a history of liver surgery or major vasculature surgery, a CT angiogram or MR angiogram is required during screening to assure the patient does not have hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting.
    16. Known varices at risk of bleeding, including medium or large esophageal or gastric varices, or active peptic ulcer.
    17. Patients with prior Whipple’s procedure.
    18. Patients with brain metastases or presence of other intracranial lesions at risk for bleeding by history or baseline radiologic imaging.
    19. Patients with an active infection, including Hepatitis B and Hepatitis C infection. Patients with anti-hepatitis B core antibody (HBc) positive, or hepatitis B surface antigen (HBsAg) but DNA negative are exception(s).
    20. Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism.
    21. Received any investigational agent for any indication within 30 days prior to first treatment.
    22. Not recovered from side effects of prior therapy to ≤ Grade 1 (according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 4.03). Certain side effects that are unlikely to develop into serious or life–threatening events (e.g. alopecia) are allowed at > Grade 1.
    23. Patients who have been institutionalized by governmental or legal decree or who are
    employees of the sponsor, Investigator, or study site.
    24. Cancers other than ocular melanoma for which the patient is currently under treatment or still deemed to be not cancer free.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy outcome measure:
    • Objective Response Rate (ORR) (complete response + partial response) as determined by Independent Central Review Committee
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study endpoint will be measured at the conclusion of Melphalan /HDS treatment
    E.5.2Secondary end point(s)
    Secondary efficacy outcome measures:
    • Duration of Response (DOR) as determined by Independent Central Review Committee
    • Disease Control Rate (DCR) determined by Independent Central Review Committee
    • Overall Survival (OS)
    • Progression Free Survival (PFS) as determined by Independent Central Review Committee
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the event that disease has not progressed at the end-of-treatment visit, disease assessment scans will continue every 12 weeks (+ 2 weeks) beginning after the date of the first treatment until disease progression is documented. All treated patients are to be contacted by phone every 3 months for survival status until death.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is determined based on the maximum observation for survival after detection of metastases; 80% of patients die within 1 year and 92% within 2 years. Therefore, patients will be followed until death.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 92
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients with progressive disease will be discontinued from study treatment, and will continue to be followed until death. An end-of-treatment visit will be conducted approx 6-8 weeks following the final study treatment. Ongoing treatment related adverse events at the end-of-treatment visit will be followed until the severity is within one of the three following parameters:
    1-Symptoms are resolved or return to baseline,
    2-CTCAE Grade < 1 or can be explained,
    3-Patient death.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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